Has the APA Assay been approved by the U.S. Food and Drug Administration for use as a diagnostic test?
No, but the test is undergoing the clinical trials necessary to support a regulatory filing for FDA approval. For diagnostic tests, the FDA requires that tests be produced in kit form, and the kit is what the FDA approves and regulates. An APA Assay kit, in the Enzyme Linked ImmunoSorbent Assay (ELISA) microtiter plate format, has been developed for Autoimmune Technologies by Corgenix, Inc., and this kit is now being used in the U.S. clinical trials. The data obtained from these trials will then be submitted to the FDA in what is called a Pre-Market Approval, or PMA, application.
